The United States Departments of Defense (DoD) and Health and Human Services (HHS) awarded $231.8 million to Ellume USA LLC this week to expand the domestic production capacity of its COVID-19 Home Test.
These funds will increase Ellume’s U.S. production capacity by 640,000 tests per day by December 2021. Approximately 8.5 million tests will also be acquired and distributed across the United States as part of the expansion. As part of the National Strategy for the COVID-19 Response and Pandemic Preparedness policy created by the Biden Administration. The Health Care Enhancement Act is funding the effort.
The test will be available for purchase without a prescription and can be used at home, without expert assistance. Notably, Ellume’s COVID-19 Home Test is the first fully at-home COVID-19 diagnostic test to have earned a Food and Drug Administration (FDA) Emergency Use Authorization (EUA) in those either with or without symptoms.
Developed with support from the National Institutes of Health’s Rapid Acceleration of Diagnostics program, the test can be performed in approximately 15 minutes, using a nasal swab specimen. Results are then reported through a smartphone app.